Events

Rappel de Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Thyroid Stimulating Hormone (TSHL) LOCI Free Thyroxine (FT4L) Thyroid Stimulating Hormone (TSH) Cardiac Troponin I (CTNI) Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01350-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-24
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01350-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    In march 2017, siemens healthcare issued an urgent recall for product correction vc 17-04 (tga ref: rc-2017-rn-01350-1) regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension and dimension vista assays. the ongoing investigation by siemens has identified the following new information regarding biotin interference:1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the affected assays. these concentrations of biotin can potentially result in interference >10%; and2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin can potentially result in interference >10%.Siemens is continuing to investigate biotin interference with our assays and more information will be forthcoming. the probability of misinterpretation of results due to this issue is unlikely.
  • Action
    Siemens is advising users of the correct biotin interference levels for the affected assays. A lookback of previously generated results is not recommended.

Device

Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Th...
  • Modèle / numéro de série
    Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD)Thyroid Stimulating Hormone (TSHL)LOCI Free Thyroxine (FT4L)Thyroid Stimulating Hormone (TSH)Cardiac Troponin I (CTNI)Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)Multiple Catalogue Numbers and SMNs (see attached)All Lots (including all future lots until the IFU is updated)ARTG Numbers: 182774, 182220, 180109 & 181687
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA